title: Real-life patterns of use and effectiveness of bortezomib: the VESUVE cohort study.
abstract: In response to a regulatory request for real-life data on patterns of use and survival outcomes, 793 patients initiating bortezomib for multiple myeloma in France (May 2004-April 2006) were included in this observational study. Data were collected from medical files and patients were followed for 2 years, with vital status collected after 3 years. In total 779 patients were analyzed: 83.1% had immunoglobulin G (IgG) or IgA M-component, mean age was 65.7 years and 46.5% were female. Bortezomib was initiated as third-or-later line in 82.0%. For 75.9%, the starting dose was 1.3 mg/m(2); 42.6% had bortezomib alone, 54.0% with dexamethasone. The mean number of bortezomib cycles was 5.0. Three-year overall survival from bortezomib initiation was 31.4% (95% confidence interval, CI [28.1; 34.7]) and median overall survival was 19.6 months. Two-year progression-free survival was 12.0% (95% CI [9.8; 14.4]), and median progression-free survival was 7.2 months. Overall best response was 44.0%. Survival outcomes during real-life use of bortezomib were within the range of those reported in clinical trials.
authors.affiliation: Inserm U657 , Bordeaux , France.
authors.forename: Annie
authors.initials: A
authors.lastname: Fourrier-Réglat
authors.forename: Pernelle
authors.initials: P
authors.lastname: Noize
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Fermand
authors.forename: Olivier
authors.initials: O
authors.lastname: Fitoussi
authors.forename: Gérald
authors.initials: G
authors.lastname: Marit
authors.forename: Patrick
authors.initials: P
authors.lastname: Thomaré
authors.forename: Philip
authors.initials: P
authors.lastname: Robinson
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Bignon
authors.forename: Jérémy
authors.initials: J
authors.lastname: Jové
authors.forename: Régis
authors.initials: R
authors.lastname: Lassalle
authors.forename: Magali
authors.initials: M
authors.lastname: Rouyer
authors.forename: Angela
authors.initials: A
authors.lastname: Grelaud
authors.forename: Nicholas
authors.initials: N
authors.lastname: Moore
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib; D015331:Cohort Studies; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone